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Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education (EDUCA)

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ClinicalTrials.gov Identifier: NCT01699282
Recruitment Status : Unknown
Verified October 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Behavioral: VKA (antivitamin K) education Behavioral: conventional hospital education Phase 3

Detailed Description:

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.
Study Start Date : July 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group thorough VKA (antivitamin K)education Behavioral: VKA (antivitamin K) education
Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education
Active Comparator: control group Behavioral: conventional hospital education
Group thorough VKA education V.S. control group (conventional hospital education)


Outcome Measures

Primary Outcome Measures :
  1. knowledge test on anticoagulant treatment [ Time Frame: after 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, male or female, over 18 years
  • After cardiac surgery
  • Requiring an oral anticoagulant in the long term (> 12 months)
  • Accepting the principle of extended follow-up
  • Voluntary Consent, written and signed by patients
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699282


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Kasra Azarnoush University Hospital, Clermont-Ferrand
More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01699282     History of Changes
Other Study ID Numbers: CHU-0121
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by University Hospital, Clermont-Ferrand:
oral anticoagulant
in the long term (> 12 months)

Additional relevant MeSH terms:
Antivitamins K
Anticoagulants